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A Phase 3 Randomized, Double-Blind Study Assessing The Efficacy And Safety Of PF-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

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Trial Profile

A Phase 3 Randomized, Double-Blind Study Assessing The Efficacy And Safety Of PF-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2025

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At a glance

  • Drugs Infliximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms REFLECTIONS B537-02
  • Sponsors Pfizer

Most Recent Events

  • 17 Mar 2025 According to a Pfizer Canada media release, IXIFI was approved by Health Canada in Dec 2021 for all eligible indications of the reference product, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (in adults and pediatric patients 9 years and older), fistulising Crohn's disease, ulcerative colitis (in adults and pediatric patients 6 years and older), psoriatic arthritis, and plaque psoriasis.
  • 14 Jan 2020 Results of long-term efficacy and safety data from weeks 54 to 78 published in the BioDrugs.
  • 24 Oct 2018 Results presented at the 82nd American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting

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